Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy

The improvement of walking capacity is a key objective of the rehabilitation of children with PC. There are different approaches from physiotherapy to address this need, including walking on the ground and on treadmill with partial weight support. Currently, there are robotic technologies adapted to the functional rehabilitation of patients. Assisted gait training with robotic devices such as the Walkbot allows a longer duration of training, at more variable speeds, and with a constant gait pattern adapted to the patient. This training, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions.

There are some studies that evaluate walking interventions on treadmill with partial weight support, on the ground and in assisted walking robot in patients with PC.

Currently, there are no studies conducted that report the effectiveness of interventions performed with robotic walking training device Walkbot K on PC. However, studies in adults with Walkbot S, affected with neurological injury, have reported good results.

Assisted gait training with robotic devices such as the Walkbot, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions. However, due to the little evidence that exists, it is necessary to know the effectiveness of the Walkbot assisted walking robot in these patients by means of a clinical trial that allows to firmly establish the scope of its benefits.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Assisted gait training with Walkbot System; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia
    • Yecla, Murcia, Spain, 30510
      • Raquel Olmos Gómez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cerebral palsy diagnosis (diplegia or tetraplegia)
• Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)
• Levels II, III and IV in GMFCS
• Unsupported seating capacity
• Go on standing with or without help
• Not receiving therapy with a walking robot and not having received it in at least one year

Exclusion Criteria:

• Serious psychiatric problems
• Serious heart problems
• Active tumors
• Severe joint degenerative problems
• Degenerative diseases of the nervous system
• Mitochondrial diseases
• Recent surgeries
• Unbound fractures
• Severe osteoporosis
• Uncontrolled seizures
• Open wounds in the lower half of the body
• Extreme fear of being placed in robotic devices
• Anthropomorphic measures are below the minimum required to use the device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Assisted gait training with Walkbot System and their usual Physical Therapy.	Device: Assisted gait training with Walkbot System; The experimental group will receive at least 3 treatment sessions per week consisting of 40 minutes in robot-assisted gait training with Walkbot System in addition to their usual Physical therapy sessions. In total, the number of Walkbot sessions will be 20, in uninterrupted weeks.; Other Names: Physical Therapy; Other: Physical Therapy; The control group will receive their usual Physical therapy sessions during 6 weeks.
Active Comparator: Control arm; Their usual Physical Therapy.	Other: Physical Therapy; The control group will receive their usual Physical therapy sessions during 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability and quality of walking.	Changes in Gross Motor Function Measure-88 (dimensions IV y V)	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality and autonomy	Differences in the basic activities of daily life, measured with the PedsQL- Cerebral Palsy Module	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Muscle strength	Differences in muscle strength of lower limbs, measured with dynamometer.	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Range of motion	Analyze if the range of joint mobility is increased in those joints that are more limited, measured with goniometer.	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Spasticity	Changes in spasticity values, measured with the modified Ashworth Scale. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 4.	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Quality of walking: Edinburgh Visual Gait Scale	Changes in Edinburgh Visual Gait Scale values. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 34.	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Gait endurance	Changes in 6 minutes walk test	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): March 14, 2021
• Study Completion (Actual): March 14, 2021

Study Registration Dates

• First Submitted: March 7, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2365/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No